Post-Market Surveillance Sr. Specialist

Job Summary:

The Post-Market Surveillance Specialist is responsible for coordinating field corrective actions, managing service report reviews, and ensuring timely return and shipment of warranty serviced products. This role also supports post-market surveillance activities, including complaint handling communication with the manufacturer on quality nonconformance and CAPA investigations experienced in regulatory reporting. The ideal candidate will be detail-oriented, collaborative, demonstrating strong skills working with diverse, international teams and experienced in medical device quality systems.

Key Responsibilities:

• Oversee execution and tracking of field corrective actions (FCAs).
• Analyze service reports for trends, issues, and follow-up actions.
• Monitor and analyze post-market data
• Ensure timely return of serviced products to the manufacturer.
• Ensure regulatory compliance, maintain compliance with FDA, EU MDR (Medical Device Regulation), ISO 13485, and other global regulatory requirements.
• Review, initiate, update, and approve non-conforming Material Reports (NCMRs).
• Support internal and external audits by providing documentation and records related to NCMRs, FCAs, complaints and or service reports
• Provide data and metrics upon request to support quality and regulatory reporting.
• Develop and implement quality procedures.
• Conduct root cause analysis and lead corrective and preventive actions (e.g. CAPA, NCM).
• Collaborate with cross-functional, diverse teams to resolve quality issues.
• Collaborate with cross-functional teams to ensure documentation reflects current product performance and safety data.
• Develop and maintain post market surveillance documentation, author and update Post-Market Surveillance Plans (PMSPs), Periodic Safety Update Reports (PSURs), and Health Hazard Evaluations (HHEs).
• Monitor and report on quality performance metrics.
• Support audits (internal, external, customer) and maintain documentation.
• Assist in continuous improvement initiatives related to quality systems and processes.
• Ensure compliance with ISO 13485 and other applicable regulatory standards.
• Lead risk management activities, participate and update risk management files, risk assessments and recommend mitigation strategies based on post-market data.
• Safety sensitive position.
• Other duties as assigned.

Project Management:

• Proficiency in Microsoft Office
• Strong technical writing, analytical and problem-solving skills
• Ability to work under minimal supervision and be proactive on tasks and project handling

Skills/Knowledge Requirements:

• Experience in quality assurance, field service coordination, and post-market surveillance.
• Strong organizational and communication skills.
• Experience with CAPA, complaint handling, and nonconformance processes.
• Ability to work cross-functionally, diverse and manage multiple priorities.
• Proficiency in data analysis and reporting tools is a plus.
• Knowledge in quality compliance, ISO 13485 and FDA a plus.
• Strong analytical and problem-solving skills.
• Excellent analytical, organizational, and communication skills.
• Experience with quality tools and methodologies (e.g., SPC, 8D, CAPA).
• Proficiency in data analysis and reporting.
• Excellent communication and teamwork abilities.

Education, Certifications and/or Work Experience Requirements:

• Bachelor's degree in Life Sciences, Engineering, Quality Assurance, or related field.
• At least 4 years’ experience in Medical Device industry.